[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Notices]
[Pages 30577-30584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15044]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0264]


Amended Authorization of Emergency Use of Doxycycline Hyclate 
Tablet Emergency Kits for Eligible United States Postal Service 
Participants in the Cities Readiness Initiative and Their Household 
Members; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the Emergency Use Authorization (EUA) (the Authorization) 
for doxycycline hyclate tablet emergency kits for eligible U.S. Postal 
Service (USPS) participants in the Cities Readiness Initiative (CRI) 
and their household members issued on October 3, 2008, under the 
Federal Food, Drug, and Cosmetic Act (the act), as requested by the 
Biomedical Advanced Research and Development Authority (BARDA), Office 
of the Assistant Secretary for Preparedness and Response (ASPR),

[[Page 30578]]

Health and Human Services (HHS). Following issuance of FDA's October 3, 
2008, Authorization letter, on February 19, 2009, BARDA submitted a 
request on behalf of ASPR, to amend the Authorization. In response to 
BARDA's request, FDA amended the Authorization letter and reissued the 
Authorization letter in its entirety on February 25, 2009. The 
Authorization, as amended and reissued in its entirety, is reprinted in 
this document.

DATES: The amended Authorization is effective as of February 25, 2009.

ADDRESSES: Submit written requests for single copies of the EUA to the 
Office of Counterterrorism and Emerging Threats (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, rm. 14C-26, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the 
Authorization may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Boris Lushniak, Office of 
Counterterrorism and Emerging Threats (HF-29), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067.

SUPPLEMENTARY INFORMATION:

I. Amendment to the October 3, 2008, Authorization for Doxycycline 
Hyclate in Emergency Kits

    On September 23, 2008, under section 564(b)(1)(A) of the the act 
(21 U.S.C. 360bbb-3(b)(1)(A)), as amended by the Project BioShield Act 
of 2004 (Public Law 108-276), the Secretary of Homeland Security 
determined that there is a significant potential for a domestic 
emergency, involving a heightened risk of attack with a specified 
biological, chemical, radiological, or nuclear agent or agents--in this 
case, Bacillus anthracis. On October 1, 2008, under section 564(b) of 
the act, and on the basis of such determination, the Secretary of HHS, 
Michael O. Leavitt, declared an emergency justifying the authorization 
of the emergency use of doxycycline hyclate tablets accompanied by 
emergency use information subject to the terms of any authorization 
issued under 21 U.S.C. 360bbb-3(a). Notice of the determination of the 
Secretary of Homeland Security and the declaration of the Secretary of 
HHS was published in the Federal Register on October 6, 2008 (73 FR 
58242).
    On October 1, 2008, BARDA requested an EUA for doxycycline hyclate 
tablet emergency kits for eligible USPS participants in CRI and their 
household members. As required under section 564(h)(1) of the act, on 
October 21, 2008, FDA published in the Federal Register notice of the 
Authorization for doxycycline hyclate tablet emergency kits for 
eligible USPS participants in the CRI and their household members, 
including an explanation of the reasons for its issuance (73 FR 62057, 
October 21, 2008). On February 19, 2009, BARDA submitted a request on 
behalf of ASPR to amend the Authorization to make certain changes to 
the written information authorized to accompany the doxycycline hyclate 
tablets and to the roles and responsibilities provided for in the 
Authorization. On February 25, 2009, in response to BARDA's request, 
FDA amended the Authorization letter and reissued the Authorization 
letter in its entirety.

II. Electronic Access

    An electronic version of this notice and the full text of the 
Authorization are available on the Internet at http://www.regulations.gov.

III. The Authorization

    After having consulted with the National Institutes of Health (NIH) 
and the Centers for Disease Control and Prevention (CDC) and having 
concluded that the criteria for issuance of this Authorization under 
section 564(c) of the act were met, on October 3, 2008, FDA authorized 
the emergency use of doxycycline hyclate tablet emergency kits for 
eligible USPS participants in the CRI and their household members. The 
letter of authorization in its entirety, as amended on February 25, 
2009, follows:
February 25, 2009
Robin Robinson, Ph.D.
Director
Biomedical Advanced Research and Development Authority (BARDA)
330 Independence Avenue SW
Room G640
Washington, DC 20201
Dear Dr. Robinson:
    This letter is in response to BARDA's October 1, 2008 
submission, as amended,\1\ requesting that the Food and Drug 
Administration (FDA) issue an Emergency Use Authorization (EUA) for 
the pre-event provision and potential use of doxycycline hyclate 
tablet emergency kits\2\ for inhalational anthrax, pursuant to 
section 564 of the Federal Food, Drug, and Cosmetic Act (the Act). 
Your request is specifically for eligible\3\ United States Postal 
Service (USPS) participants in the Cities Readiness Initiative (CRI) 
(hereinafter USPS participants) and their household members.\4\
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    \1\ BARDA submitted an amendment on October 3, 2008. Following 
issuance of FDA's October 3, 2008, authorization letter, BARDA 
submitted a request on behalf of the Office of the Assistant 
Secretary for Preparedness and Response (ASPR) on February 19, 2009, 
to further amend the authorization. This amended authorization 
letter responds to that request.
    \2\ Your submissions refer to a Household Antibiotic Kit (HAK), 
which would be stored in an eligible United States Postal Service 
(USPS) participant's home and would contain unit-of-use bottles of 
doxycycline hyclate tablets (100 mg) and both emergency use 
instructions and home preparation instructions. Your submissions 
also refer to an individual Household Antibiotic Kit (iHAK), which 
would be stored at an eligible USPS participant's workplace and 
would contain only one unit-of-use bottle of doxycycline hyclate 
tablets (100 mg) and emergency use instructions. For ease of 
reference, this letter of authorization will use the term 
``doxycycline hyclate tablet emergency kit(s)'' to refer to both 
types of kits, unless otherwise specified. When referring to the 
kits separately, this letter will use the term ``household 
doxycycline hyclate tablet emergency kit'' to refer to the HAK and 
the term ``individual doxycycline hyclate tablet emergency kit'' to 
refer to the iHAK.
    \3\ The term ``eligible'' refers to USPS participants who have 
agreed in writing to participate in the Postal Module of CRI, have 
been screened for fitness to receive OSHA-required personal 
protective equipment, have (including household members) been 
medically screened for contraindications based on completed health 
assessment forms, have (including household members) been given a 
valid prescription, and have (including household members) not 
otherwise been determined to be ineligible to receive doxycycline 
hyclate tablet emergency kits.
    \4\ Your submissions define ``household member'' as ``anyone 
that considers that address as his or her permanent place of 
residence.''
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    On September 23, 2008, pursuant to section 564(b)(1)(A) of the 
Act, 21 U.S.C. Sec.  360bbb-3(b)(1)(A), the Secretary of the 
Department of Homeland Security determined that there is a 
significant potential for a domestic emergency, involving a 
heightened risk of attack with a specified biological, chemical, 
radiological, or nuclear agent or agents--in this case, Bacillus 
anthracis.\5\ On October 1, 2008, pursuant to section 564(b) of the 
Act, and on

[[Page 30579]]

the basis of such determination, the Secretary of the Department of 
Health and Human Services declared an emergency justifying the 
authorization of the emergency use of doxycycline hyclate tablets 
accompanied by emergency use information subject to the terms of any 
authorization issued under 21 U.S.C. Sec.  360bbb-3(a).\6,7\ Having 
consulted with the National Institutes of Health (NIH) and the 
Centers for Disease Control and Prevention (CDC), and having 
concluded that the criteria for issuance of this authorization under 
section 564(c) of the Act are met, I am authorizing the emergency 
use of doxycycline hyclate tablet emergency kits for the post-
exposure prophylaxis of inhalational anthrax for eligible USPS 
participants and their household members,\8\ subject to the terms of 
this authorization.
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    \5\ Memorandum from Michael Chertoff to Michael O. Leavitt, 
Determination Pursuant to Sec.  564 of the Federal Food, Drug, and 
Cosmetic Act (Sept. 23, 2008).
    \6\ Declaration of Emergency Pursuant to Section 564 of the 
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b) (Oct. 1, 
2008).
    \7\ The doxycycline hyclate tablet emergency kits for eligible 
USPS participants and their household members referenced and 
authorized in this letter fall within the scope of the Secretary of 
the Department of Health and Human Services' declaration.
    \8\ Doxycycline hyclate tablets are indicated for treatment of 
infections caused by ``Anthrax due to Bacillus anthracis, including 
inhalational anthrax (post-exposure): to reduce the incidence or 
progression of disease following exposure to aerosolized Bacillus 
anthracis.'' This indication generally means that drug 
administration is expected to start after a known or suspected 
exposure to aerosolized Bacillus anthracis spores, but before 
clinical symptoms of the disease develop. The indication includes 
presumed exposure, since it is often difficult to know whether and 
when exposure has actually occurred. The indication also encompasses 
instances where Bacillus anthracis exposure via inhalation is 
expected and will be imminent. In such cases, the first few doses of 
prophylaxis may be taken pre-exposure, but the remainder of the 
course would be taken post-exposure. The indication is commonly 
referred to as ``post-exposure prophylaxis of inhalational 
anthrax,'' and this term will be used throughout this letter for 
ease of reference.
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    The remainder of this letter is organized into four sections: 
Background, Criteria for Issuance of Authorization, Scope of 
Authorization, Conditions of Authorization, and Duration of 
Authorization.

I. Background

    CRI involves 72 major metropolitan areas and all 50 states. The 
primary goal of CRI is to develop the ability to provide mass 
prophylaxis to 100% of the identified population within 48 hours of 
notification to do so.
    On February 18, 2004, the Secretary of the Department of Health 
and Human Services (HHS), the Secretary of the Department of 
Homeland Security (DHS), and the Postmaster General signed a 
Memorandum of Agreement to explore how the resources of the USPS 
could be made available to help deliver oral antibiotics in response 
to a biological terrorism incident. Subsequently, HHS launched CRI 
and asked the USPS to participate in what has been referred to as 
the CRI Postal Module (or Postal Plan). The Postal Module involves 
the delivery of antibiotics to residential households within pre-
determined zip codes by USPS participants where there may be an 
intentional release of Bacillus anthracis in their geographic area. 
The CRI Postal Module could be activated and executed while the 
municipality is establishing its points-of-dispensing (POD) network 
for the remainder of the emergency response which, in the case of a 
wide-area anthrax event, could continue for 1-2 months. The postal 
carriers' role is voluntary because emergency response is neither 
part of the basic mission of USPS nor a provision of the contracts 
between USPS and the unions representing the carriers. USPS has made 
its participation in the CRI Postal Module contingent on the pre-
event provision of prescription antibiotic countermeasures to USPS 
participants and their household members.
    Your request relates to a potential EUA for the pre-event 
provision and potential use of doxycycline hyclate tablets (100 mg) 
in the form of emergency kit(s) for eligible USPS participants and 
their household members. Although doxycycline hyclate tablets are 
approved for the post-exposure prophylaxis of inhalational anthrax, 
the emergency kits you describe in your submissions would require an 
EUA because they would include certain written information that is 
not currently part of the approved new drug applications (NDAs) or 
abbreviated new drug applications (ANDAs) for doxycycline hyclate 
tablets (100 mg). Specifically, you indicated that the following 
pieces of written information would accompany the doxycycline 
hyclate tablets:
     Fact Sheet for Recipients
     For the household doxycycline hyclate tablet emergency 
kit, home preparation instructions for recipients who cannot swallow 
pills (hereinafter home preparation instructions)
     Information placard (unless the bag is pre-printed with 
placard information)
     MedWatch Form 3500 for the reporting of any adverse 
events associated with the doxycycline hyclate tablet emergency kit
    In addition, a Fact Sheet for Health Care Providers would be 
distributed to health care providers and authorized dispensers of 
the doxycycline hyclate tablet emergency kits.
    You propose to use doxycycline hyclate tablets (100 mg) that 
were manufactured by West-Ward Pharmaceutical Corp., and repackaged 
by PD-Rx Pharmaceuticals into unit-of-use bottles containing 20 oral 
tablets each, a 10-day supply.\9\
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    \9\ We note that the full course of doxycycline hyclate tablets 
for adults for the post-exposure prophylaxis of inhalational anthrax 
is 100 mg twice daily for 60 days. The corresponding oral dosing 
regimen for children under 100 pounds is 1 mg per pound of body 
weight twice daily for 60 days.
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    The doxycycline hyclate tablet emergency kit(s) that are the 
subject of your request would come in two forms. The first, which 
you describe as a Household Antibiotic Kit (HAK), would contain a 
unit-of-use bottle of doxycycline hyclate tablets for each eligible 
USPS participant and each eligible household member, as well as the 
Fact Sheet for Recipients, home preparation instructions, MedWatch 
Form 3500, and information placard (unless bag is pre-printed with 
placard information) described above. All of these items would be 
placed in one tamper-evident, clear plastic bag for home storage. 
The second, which you describe as an individual Household Antibiotic 
Kit (iHAK), would contain one unit-of-use bottle of doxycycline 
hyclate tablets for the eligible USPS participant and the Fact Sheet 
for Recipients, MedWatch Form 3500, and information placard (unless 
the bag is pre-printed with placard information) described above. 
All of these items would be placed in a separate tamper-evident, 
clear plastic bag for secure storage at the USPS participant's 
workplace, should the USPS participant need to deploy emergently.

II. Criteria for Issuance of Authorization

    Having considered the September 23, 2008 determination by the 
Secretary of the Department of Homeland Security that there is a 
significant potential for a domestic emergency, involving a 
heightened risk of attack with a biological, chemical, radiological, 
or nuclear agent or agents--in this case, Bacillus anthracis, and 
the October 1, 2008 declaration of emergency by the Secretary of 
Health and Human Services, and having consulted with NIH and CDC, I 
have concluded that the emergency use of doxycycline hyclate tablet 
emergency kits for the post-exposure prophylaxis of inhalational 
anthrax for eligible USPS participants and their household members 
meets the criteria for issuance of an authorization under section 
564(c) of the Act, because I have concluded that:
    (1) Bacillus anthracis can cause anthrax, a serious or life-
threatening disease or condition;
    (2) based on the totality of scientific evidence available to 
FDA, it is reasonable to believe that doxycycline hyclate tablet 
emergency kits may be effective for post-exposure prophylaxis of 
inhalational anthrax,\10\ and that the known and potential benefits 
of doxycycline hyclate tablet emergency kits, when used for the 
post-exposure prophylaxis of inhalational anthrax in the specified 
population, outweigh the known and potential risks of the product; 
and
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    \10\ The Act uses the terms ``diagnosing, treating, or 
preventing'' in Section 564(c)(2)(A). Post-exposure prophylaxis is 
encompassed by these statutory terms.
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    (3) there is no adequate, approved, and available alternative to 
doxycycline hyclate tablet emergency kits for the post-exposure 
prophylaxis of inhalational anthrax.\11\
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    \11\ No other criteria of issuance have been prescribed by 
regulation under section 564(c)(4) of the Act.
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    Specifically, I have concluded, pursuant to section 564(c)(1) of 
the Act, that Bacillus anthracis can cause inhalational anthrax, 
which is a serious or life-threatening disease or condition. The 
fatality rate for inhalational anthrax in the United States is 
estimated to be approximately 45 percent to 90 percent. From 1900 to 
October 2001, there were 18 identified cases of inhalational anthrax 
in the United States, the latest of which was reported in 1976, with 
an 89 percent (16/18) mortality rate. Most of these exposures 
occurred in industrial settings, i.e., textile mills. From October 
4, 2001, to December 5, 2001, a total of 11 cases of inhalational 
anthrax linked to intentional dissemination of Bacillus anthracis 
spores were identified in the United States. Five of these cases 
were fatal. These fatalities occurred despite aggressive medical 
care, including treatment with antimicrobial drugs.
    I have also concluded that, based on the totality of the 
scientific evidence available to FDA, including data supporting the 
safe and effective use of doxycycline hyclate tablets (100 mg) for 
the post-exposure prophylaxis of inhalational anthrax, the results 
of CDC's home MedKit study, and information associated with the 
development of the home preparation instructions, it is reasonable 
to believe that doxycycline hyclate tablet emergency kits may be 
effective for the post-exposure prophylaxis of inhalational anthrax 
pursuant to section 564(c)(2)(A) of the Act.
    The above conclusion is largely based on the fact that FDA has 
previously approved a number of NDAs and ANDAs for doxycycline 
hyclate tablets for the treatment and post-exposure prophylaxis of 
inhalational anthrax, as summarized below.
    In November 2001, as part of a public health response to the use 
of anthrax spores

[[Page 30580]]

as a bioterrorism agent, the Agency published a notice in the 
Federal Register that clarified the dosing recommendations for, 
among others, doxycycline hyclate products, in the management of 
patients with inhalational anthrax who had been exposed to spores of 
Bacillus anthracis, but who did not manifest clinical disease.\12\ 
In that notice, FDA announced that it had determined that the 
language in the labeling of certain drug products, including those 
containing doxycycline hyclate, is intended to, and does, cover all 
forms of anthrax, including inhalational anthrax (post-exposure): to 
reduce the incidence or progression of disease exposure to 
aerosolized B. anthracis. FDA also announced that the appropriate 
dosing regimen for adults is 100 mg of doxycycline, taken orally 
twice daily for 60 days; and the corresponding oral dosing regimen 
for children under 100 pounds is 1 mg per pound (1 mg/lb) of body 
weight (2.2 mg/kilogram (kg)), given twice daily for 60 days.\13\ 
FDA based these conclusions on the following:
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    \12\ See 66 Fed. Reg. 55679 (Nov. 2, 2001); Docket 01N-0494.
    \13\ Id. The Federal Register notice further requested that 
applicants for these products submit labeling supplements to update 
their package inserts with this information.
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     Effectiveness was supported by minimal inhibitory 
concentration (MIC) data for the tetracycline class and Bacillus 
anthracis, pharmacokinetic data, data from the Sverdlovsk incident, 
and the outcome data from a study of inhalational exposure to 
Bacillus anthracis in rhesus monkeys.
     With respect to safety, FDA noted that doxycycline drug 
products have been used for over 30 years and the literature on the 
products is voluminous. FDA previously reviewed the literature 
dealing with the long-term administration of doxycycline for 
treatment of diseases other than anthrax. Several articles reported 
the results of studies involving the administration of doxycycline 
in amounts comparable to the recommended doses. They also involved 
administration of doxycycline for 60 days and periods approaching 
and exceeding 60 days. FDA also reviewed data from the Adverse Event 
Reporting System (AERS). Analysis of these articles and data 
indicated no pattern of unlabeled adverse events associated with the 
long-term use of doxycycline.
     FDA also noted that doxycycline and other members of 
the tetracycline class of antibiotics are not generally indicated 
for the treatment of any patients under the age of 8 years. 
Tetracyclines are known to be associated with teeth discoloration 
and enamel hypoplasia in children and delays in bone development in 
premature infants after prolonged use. FDA balanced the nature of 
the effect on teeth and the fact that this delay in bone development 
is apparently reversible against the lethality of inhalational 
anthrax, and concluded that doxycycline drug products can be labeled 
with a pediatric dosing regimen for inhalational anthrax (post-
exposure).
    As noted above, FDA has approved, under section 505(j) of the 
Act, a number of abbreviated new drug applications (ANDAs), 
including West-Ward's ANDA (65-095) for doxycycline hyclate 
tablets (100 mg) for treatment and post-exposure prophylaxis of 
inhalational anthrax on July 2, 2003. West-Ward's doxycycline 
hyclate tablets (100 mg), which have been repackaged and re-labeled 
by PD-Rx Pharmaceuticals, are the subject of this emergency use 
authorization. This product is the same as the reference listed 
drug, Vibra-Tabs (doxycycline hyclate tablets, 100 mg; NDA 
50-333), within the meaning of section 505(j) of the Act.
    I have also considered CDC's home MedKit study and information 
associated with the development of the home preparation instructions 
as part of the totality of the scientific evidence available to FDA, 
and have determined that this information helps to support the 
conclusion that it is reasonable to believe that doxycycline hyclate 
tablet emergency kits may be effective for post-exposure prophylaxis 
of inhalational anthrax, as summarized below.
    The CDC study evaluated the ability of study participants to 
receive what was referred to as a MedKit -- doxycycline\14\ with 
certain written information, including emergency use instructions 
and home preparation instructions similar to those being authorized 
here. A convenience sample of 4,250 St. Louis area households, 
divided among three cohorts, was enrolled in the study after medical 
screening and informed consent. The primary outcomes for this 
evaluation were to determine the extent to which participants would 
follow instructions for appropriately keeping the MedKits intact and 
reserving them for emergency use until directed by a local 
government official. Although this study had a number of limitations 
as explained below, approximately 97% of all study respondents 
returned the MedKits upon completion of the study.
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    \14\ In this study, participants who were allergic to 
doxycycline or for whom doxycycline was otherwise contraindicated 
received ciprofloxacin.
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    Finally, FDA considered information associated with the 
development of the home preparation instructions for doxycycline 
hyclate tablets. FDA had previously developed home preparation 
instructions and these instructions were tested by the Chicago 
Department of Public Health, which provided its results to FDA. The 
Agency revised the home preparation instructions based on these 
findings and performed additional laboratory tests and limited 
palatability testing. FDA also worked with CDC to improve the 
readability of the instructions.
    Although FDA has approved a number of NDAs and ANDAs for 
doxycycline hyclate tablets (100 mg) for the treatment and post-
exposure prophylaxis of inhalational anthrax, these products are not 
approved with emergency use instructions and home preparation 
instructions. The amount and nature of the scientific evidence 
regarding the ability to use emergency use instructions and home 
preparation instructions is more limited than the scientific 
evidence supporting the approval of doxycycline hyclate tablets for 
the post-exposure prophylaxis of inhalational anthrax. However, 
taking into consideration the potentially fatal nature of anthrax 
disease, the CDC home MedKit study and the information associated 
with the development of the home preparation instructions also helps 
to support a conclusion that it is reasonable to believe that 
doxycycline hyclate tablet emergency kits may be effective for the 
post-exposure prophylaxis of inhalational anthrax. Accordingly, 
based on the totality of the scientific evidence available to FDA, 
it is reasonable to believe that doxycycline hyclate tablet 
emergency kits may be effective for the post-exposure prophylaxis of 
inhalational anthrax.
    I have also concluded, pursuant to section 564(c)(2)(B) of the 
Act, that it is reasonable to believe that the known and potential 
benefits of doxycycline hyclate tablet emergency kits outweigh the 
known and potential risks of the product for USPS participants and 
their household members. The available scientific evidence that 
supports this conclusion is summarized below.
    We have already concluded, as evidenced by the previous NDA and 
ANDA approvals discussed above, that the known and potential 
benefits of the approved doxycycline hyclate tablets (100 mg) for 
post-exposure prophylaxis of inhalational anthrax outweigh the known 
and potential risks of the product. Under this EUA, doxycycline 
hyclate tablets will be packaged with additional written information 
(including emergency use instructions and home preparation 
instructions) that has not been approved by FDA as part of a new 
drug application. CDC's home MedKit study and the process by which 
home preparation instructions were developed, as discussed above, 
help to further inform the requisite risk-benefit analysis under 
section 564(c)(2)(B).
    The CDC home MedKit study was somewhat limited in its ability to 
address certain questions about home storage and use since the 
participants were not required to follow any directions for 
preparation or use of doxycycline hyclate tablets in an actual 
emergency. The effect of the actual storage conditions on the stored 
drug product was not tested and the instructions for storage did not 
provide the temperature conditions for storage on the outside of the 
bag. Despite the limitations of the CDC home MedKit study, it is 
important to note that approximately 97% of all study respondents 
returned the MedKits upon completion of the study.
    As described above, the development of the home preparation 
instructions has been informed by limited testing and input from 
CDC. However, the current version of the home preparation 
instructions has not been subjected to formal independent testing 
procedures for an assessment of an individual's understanding or 
his/her ability to follow the directions.
    Because of the limitations of the CDC study and the lack of 
formal independent testing on the home preparation instructions, FDA 
cannot conclude without further testing and

[[Page 30581]]

information that the emergency use instructions and home preparation 
instructions pose no additional risks to eligible USPS participants 
and their household members. Inappropriate use and the development 
of doxycycline resistant microorganisms could be a potential issue 
if a considerable number of eligible USPS participants take the 
product for an unintended purpose.
    The known and potential risks of eligible USPS participants and 
their household members not being able to store, prepare, and use 
doxycycline hyclate tablets in accordance with the emergency use 
instructions and home preparation instructions, and of experiencing 
adverse reactions, is outweighed by the known and potential benefits 
of using doxycycline hyclate tablets as a safe and effective 
treatment against an otherwise potentially fatal aerosolized anthrax 
attack. For the foregoing reasons, it is reasonable to believe that 
the known and potential benefits of the doxycycline hyclate tablet 
emergency kits (including emergency instructions and home 
preparation instructions as authorized) for the post-exposure 
prophylaxis of inhalational anthrax in the specified population 
outweigh the known and potential risks of the product under the 
terms of this letter of authorization.\15\
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    \15\ The terms of this letter of authorization, including its 
scope and conditions, are integral to the conclusions regarding the 
known and potential risks and benefits of the emergency use of this 
product in eligible USPS participants and their household members.
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    I have also concluded, pursuant to section 564(c)(3) of the Act, 
that there is no adequate, approved, and available alternative to 
the doxycycline hyclate tablet emergency kits for post-exposure 
prophylaxis of inhalational anthrax in the specified population. 
Although doxycycline hyclate is approved for treatment and post-
exposure prophylaxis of inhalational anthrax, the emergency use 
instructions and home preparation instructions included here as part 
of the doxycycline hyclate tablet emergency kits are not approved by 
FDA.
    Other products approved for treatment and post-exposure 
prophylaxis of inhalational anthrax include penicillin G procaine, 
ciprofloxacin, and levofloxacin. However, none of these products is 
approved with emergency use instructions. In addition, penicillin G 
procaine is administered by injection and fluoroquinolones 
(ciprofloxacin and levofloxacin) have additional significant adverse 
events reported following their use, including adverse tendon 
effects and rupture, peripheral neuropathy, and central nervous 
system disorders.
    Further, Biothrax (Anthrax Vaccine Adsorbed) is indicated for 
the active immunization against Bacillus anthracis of individuals 
between 18 and 65 years of age who come in contact with animal 
products such as hides, hair or bones that come from anthrax endemic 
areas, and that may be contaminated with Bacillus anthracis spores. 
This product is not considered an ``adequate, approved, and 
available'' alternative for several reasons including: (1) the 
license for Biothrax does not extend to post exposure use; (2) the 
immunization consists of three subcutaneous injections given 2 weeks 
apart followed by three additional subcutaneous injections given at 
6, 12 and 18 months; and (3) following the initial injections, time 
is needed to develop the antibodies. Therefore, I have concluded 
that there is no adequate, approved, and available alternative to 
doxycycline hyclate tablet emergency kits for the post-exposure 
prophylaxis of inhalational anthrax for the specified population.

III. Scope of Authorization

    Pursuant to section 564(d)(1) of the Act, this authorization is 
limited to the use of doxycycline hyclate tablet emergency kits for 
the post-exposure prophylaxis of inhalational anthrax\16\ for 
eligible\17\ USPS participants in the Postal Module of CRI and their 
household members.
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    \16\ See footnote 8.
    \17\ See footnote 3.
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    The doxycycline hyclate tablets authorized under this EUA were 
manufactured by West-Ward Pharmaceutical Corp. and have been 
repackaged into unit-of-use bottles containing 20 tablets (a 10-day 
supply) by PD-Rx Pharmaceuticals, consistent with current Good 
Manufacturing Practice (CGMP) and the Draft Guidance entitled 
``Expiration Dating of Unit-Dose Repackaged Drugs; Compliance Policy 
Guide.'' The product has been stored under conditions consistent 
with the manufacturer's labeled storage conditions and CGMP and is 
within its labeled expiration date. Once doxycycline hyclate tablets 
covered by this EUA have passed their expiration date, they are 
outside the scope of this EUA.
    ASPR will determine whether to initiate distribution of product 
under this EUA to particular CRI locations based on:
(a) whether the municipality has submitted a Strategic Security Plan 
acceptable to USPS and ASPR;
(b) whether the municipality, in collaboration with pertinent State 
public health officials, local law enforcement agencies, USPS, ASPR, 
and other appropriate entities, has developed a mutually acceptable 
set of policies and procedures for recruiting USPS participants, 
screening them for fitness to receive doxycycline hyclate tablets, 
providing the doxycycline hyclate tablet emergency kits to eligible 
USPS participants and their household members, and maintaining the 
readiness of the participant force. Policies and procedures must 
also include screening for fitness to receive OSHA-required personal 
protective equipment (PPE) (i.e., N95 masks) and provision of PPE to 
eligible USPS participants;\18\
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    \18\ The emergency use of unapproved, unlicensed, or uncleared 
PPE or the unapproved use of approved, licensed, or cleared PPE is 
not authorized as part of this EUA.
---------------------------------------------------------------------------

(c) whether ASPR has determined that it has sufficient funds to 
cover the costs of CRI Postal Module implementation in that 
location.
    After the distribution decision has been made by ASPR and 
conveyed to FDA, the unit-of-use bottles will be delivered to secure 
site(s), where the participating public health authority(ies) will 
assume control over them. Under this EUA, the unit-of-use bottles 
will be repackaged and relabeled\19\ into doxycycline hyclate tablet 
emergency kits by licensed health care providers under the auspices 
of the participating public health authority(ies).
---------------------------------------------------------------------------

    \19\ The term ``repackaged and relabeled'' will be used to refer 
to the activity of putting unit-of-use bottles into clear, tamper-
evident bags with the addition of certain written information.
---------------------------------------------------------------------------

    I have concluded, pursuant to section 564(d)(2) of the Act, that 
it is reasonable to believe that the known and potential benefits of 
the doxycycline hyclate tablet emergency kits, when used for the 
post-exposure prophylaxis of inhalational anthrax, outweigh the 
known and potential risks of the product for the population 
described above.
    I have concluded, pursuant to section 564(d)(3) of the Act, 
based on the totality of scientific evidence available to FDA, that 
it is reasonable to believe that the doxycycline hyclate tablet 
emergency kits may be effective for the post-exposure prophylaxis of 
inhalational anthrax pursuant to section 564(c)(2)(A) of the Act. 
FDA has reviewed the scientific information available, including the 
information described in Section II above, and concludes that the 
doxycycline hyclate tablet emergency kits, when used for the post-
exposure prophylaxis of inhalational anthrax in the specified 
population, meet the criteria set forth in section 564(c) of the Act 
concerning safety and potential effectiveness.
    The pre-event distribution and use of doxycycline hyclate tablet 
emergency kits under this EUA must conform to and may not exceed the 
terms of this letter of authorization, including the scope and the 
conditions of authorization set forth below. Subject to the terms of 
this EUA and under the circumstances set forth in the Secretary of 
Homeland Security's determination under section 564(b)(1)(A) 
described above and the Secretary of HHS's corresponding declaration 
under section 564(b)(1), doxycycline hyclate tablet emergency kits 
are authorized for the post-exposure prophylaxis of inhalational 
anthrax for eligible USPS participants and their household members.
    This EUA will cease to be effective when the declaration of 
emergency is terminated under section 564(b)(2) of the Act or when 
the EUA is revoked under section 564(g) of the Act. When the EUA 
ceases to be effective, doxycycline hyclate tablet emergency kits 
will no longer be authorized for emergency use under this EUA, and 
doxycycline hyclate tablet emergency kits that have been distributed 
under this EUA must be collected as described in this letter of 
authorization.

IV. Conditions of Authorization

    Pursuant to section 564 of the Act, I am establishing the 
following conditions on this authorization:
    A. BARDA will provide to the participating public health 
authority(ies) the written materials included in BARDA's October 3, 
2008 submission, as amended on February 19, 2009, and authorized 
under this EUA.
    B. The participating public health authority(ies) will conduct 
an educational and information program under appropriate

[[Page 30582]]

conditions designed to ensure that health care providers or other 
authorized dispensers (hereinafter health care providers) 
distributing doxycycline hyclate tablet emergency kits are informed:
    (1) that FDA has authorized the emergency use of doxycycline 
hyclate tablet emergency kits for the post-exposure prophylaxis of 
inhalational anthrax for eligible USPS participants and their 
household members;
    (2) of the significant known and potential benefits and risks of 
the emergency use of doxycycline hyclate tablet emergency kits, and 
of the extent to which such benefits and risks are unknown for 
eligible USPS participants and their household members; and
    (3) of the alternatives to doxycycline hyclate tablet emergency 
kits for eligible USPS participants and their household members, and 
of their benefits and risks.
    With respect to condition (2) above, relating to provision of 
the significant known and potential benefits and risks of the 
emergency use of doxycycline hyclate tablet emergency kits, the 
participating public health authority(ies) will ensure that the 
manufacturer's package insert is provided to all health care 
providers who distribute doxycycline hyclate tablet emergency kits 
to eligible USPS participants and their household members. With 
respect to conditions (1) - (3), the participating public health 
authority(ies) will ensure that health care providers are provided 
with the authorized Fact Sheet for Health Care Providers. Any 
revision to the authorized Fact Sheet for Health Care Providers is 
subject to FDA's prior approval. The participating public health 
authority(ies) will also ensure that all such health care providers 
are provided with the same information as that provided to eligible 
recipients described immediately below.
    C. The participating public health authority(ies) will conduct 
an educational and information program under appropriate conditions 
designed to ensure that individuals to whom doxycycline hyclate 
tablet emergency kits are distributed are informed:
    (1) that FDA has authorized the emergency use of doxycycline 
hyclate tablet emergency kits for the post-exposure prophylaxis of 
inhalational anthrax for eligible USPS participants and their 
household members;
    (2) of the significant known and potential benefits and risks of 
the emergency use of doxycycline hyclate tablet emergency kits for 
eligible USPS participants and their household members, and of the 
extent to which such benefits and risks are unknown; and
    (3) of the option to accept or refuse administration of 
doxycycline hyclate tablet emergency kits, of the consequences, if 
any, of refusing administration of the product, and of the 
alternatives to the product that are available, and of their 
benefits and risks.
    As a condition of this authorization, the participating public 
health authority(ies) will ensure that, prior to distribution of 
doxycycline hyclate tablet emergency kits, the authorized 
information that meets the requirements set forth above is provided 
to each eligible recipient (i.e., in the case of the household 
doxycycline hyclate emergency kit, the Fact Sheet for Recipients, 
home preparation instructions, and information placard (or bag pre-
printed with placard information); in the case of the individual 
doxycycline hyclate emergency kit, the Fact Sheet for Recipients, 
and information placard (or bag pre-printed with placard 
information)). Any revision to the authorized information for 
potential recipients is subject to FDA's prior approval.
    D. The participating public health authority(ies) will 
distribute doxycycline hyclate tablet emergency kits to eligible 
recipients through health care providers who are qualified and 
licensed under applicable state law to dispense prescription drugs. 
The health care providers will distribute doxycycline hyclate tablet 
emergency kits under conditions that assure that otherwise 
eligible\20\ recipients are screened for medical eligibility 
(including contraindications) and are issued prescriptions for the 
doxycycline hyclate tablet emergency kit. Such conditions shall 
include exclusion of a USPS participant if:
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    \20\ USPS postal carriers are not eligible to receive a 
doxycycline hyclate tablet emergency kit if they have not passed 
their N95 mask fit test. See Section III, Scope of Authorization, 
above.
---------------------------------------------------------------------------

     No medical history and Health Assessment Form is 
available for the USPS participant or any member of their household; 
or
     Doxycycline hyclate is contraindicated for the USPS 
participant.
    The participating public health authority(ies) must ensure 
documentation of eligibility or ineligibility to receive doxycycline 
hyclate tablet emergency kits. If doxycycline hyclate tablets are 
contraindicated for any of the USPS participant's household members, 
the USPS participant can still receive the doxycycline hyclate 
tablet emergency kit if s/he consents in writing to accept an 
incomplete kit and acknowledges that the household member(s) will 
have the same dependence on whatever community-based mass 
prophylaxis is available to the general public in an emergency.
    USPS will be responsible for providing copies of the authorized 
Health Assessment Form to potential USPS participants. If they elect 
to apply for participation, potential USPS participants and their 
household members should complete Health Assessment Forms and mail 
them to the participating public health authority(ies) at the 
address provided. Qualified health care providers, under the 
auspices of the participating public health authority(ies), will be 
responsible for reviewing the completed Health Assessment Forms to 
determine whether potential recipients are eligible to receive 
doxycycline hyclate tablet emergency kits prior to dispensing such 
kits to eligible USPS recipients . Any revision of the authorized 
Health Assessment Form is subject to FDA's prior approval. A health 
care provider will review with each USPS participant his/her Health 
Assessment Form and the Health Assessment Form corresponding to each 
family member and will comply with applicable state prescribing laws 
before authorizing the filling of one unit-of-use bottle for each 
eligible USPS participant and household member. See Section D below 
for requirements regarding repackaging and relabeling of doxycycline 
hyclate tablet emergency kits prior to dispensing to eligible 
recipients.
    E. Doxycycline hyclate tablet emergency kits must be 
manufactured, (re)packaged, (re)labeled, and held according to 
applicable good manufacturing practice requirements, except that 
with respect to the doxycycline hyclate tablet emergency kits that 
will be repackaged and relabeled by participating local public 
health authorities using the doxycycline unit-of-use bottles 
manufactured by West-Ward Pharmaceutical Corp. and repackaged by PD-
Rx Pharmaceuticals described in this EUA, the Secretary waives good 
manufacturing practice requirements applicable to the repackaging 
and relabeling of such kits, subject to the following requirements
     The participating public health authority(ies) will be 
responsible for repackaging and relabeling doxycycline hyclate unit-
of-use bottles into doxycycline hyclate tablet emergency kits 
through health care providers qualified and licensed under state law 
to dispense prescription drugs.
     The packaging and relabeling described below should be 
performed in a controlled environment such that there is adequate 
space, lighting, and freedom from debris and from other drug 
products to prevent mix-ups or cross-contamination.
     A health care provider who initially assembles the 
doxycycline hyclate tablet emergency kits will do the following:
    [cir] The health care provider will determine the number of 
authorized individuals in a household eligible to receive the 
product using the completed Health Assessment Form. The health care 
provider will document the prescription number, lot number, and 
expiration date of doxycycline hyclate for each authorized 
individual.
    [cir] The health care provider will record all prescription 
numbers for the household on the Healthcare Provider Quality 
Checklist.
    [cir] The health care provider will be responsible for 
maintaining an inventory/drug accountability record. At a minimum, 
this record will contain a running total/balance, the date filled, 
household name, and number of unit-of-use bottles dispensed to a 
household. The prescription number, lot number, and expiration date 
of the doxycycline hyclate tablets for each authorized individual 
will also be recorded.
    [cir] For the household doxycycline hyclate tablet emergency 
kit, the health care provider will place the correct number of unit-
of-use bottles of doxycycline hyclate (corresponding to the 
authorized USPS participant and each authorized

[[Page 30583]]

household member) in one clear, tamper-evident plastic bag. Each 
unit-of-use bottle will be labeled with the appropriate authorized 
individual's name.
    [cir] For an individual doxycycline hyclate tablet emergency 
kit, the health care provider will place one unit-of-use bottle of 
doxycycline hyclate tablets in a separate clear, tamper-evident 
plastic bag for the authorized USPS participant for secure storage 
by the USPS at work. The unit-of-use bottle will be labeled with the 
authorized USPS participant's name.
    [cir] For the household doxycycline hyclate tablet emergency 
kit, the health care provider will place the Fact Sheet for 
Recipients, home preparation instructions, and MedWatch Form 3500 
inside and in the outer pocket of the clear, tamper-evident plastic 
bag; and, if the bag is not pre-printed with placard information, 
the health care provider will place the information placard inside 
the bag facing out so the wording is plainly visible.
    [cir] For the individual doxycycline hyclate tablet emergency 
kit, the health care provider will place the Fact Sheet for 
Recipients and MedWatch Form 3500 Form inside and in the outer 
pocket of the clear, tamper-evident plastic bag; and, if the bag is 
not pre-printed with placard information, the health care provider 
will place the information placard inside the bag facing out so the 
wording is plainly visible.
    [cir] The health care provider will complete the first page of 
the Healthcare Provider Quality Checklist, including signature and 
date.
    [cir] The health care provider will not seal the bag, and will 
give it to the identified health care provider to check the contents 
of the bags as described below.
     Before dispensing, a different health care provider 
will check each doxycycline hyclate tablet emergency kit that has 
been assembled as follows:
    [cir] Review and verify Health Assessment Forms for eligibility 
of USPS participant and each household member to receive the 
doxycycline hyclate tablet emergency kit.
    [cir] Verify that each unit-of-use bottle is labeled with the 
authorized individual's name.
    [cir] Verify the prescription number, lot number, and expiration 
date of the doxycycline hyclate tablets for each authorized 
individual on the Health Assessment Forms.
    [cir] Verify prescription numbers for each authorized individual 
on the Healthcare Provider Quality Checklist.
    [cir] For the household doxycycline hyclate tablet emergency 
kit, verify that the correct number of unit-of-use bottles of 
doxycycline hyclate tablets have been placed in the tamper-evident 
bag for that household based on the number of household members 
eligible. For the individual doxycycline hyclate tablet emergency 
kit, verify that the correct unit-of-use bottle of doxycycline 
hyclate tablets has been placed in the tamper-evident bag for the 
USPS participant for secure storage by USPS at work.
    [cir] Verify that the appropriate written information is inside 
the tamper-evident bags.
    [cir] Verify that the appropriate written information is in the 
outer pocket of the tamper-evident bags.
    [cir] If the information placard is not pre-printed on the 
outside of the tamper-evident bags, verify that the information 
placard is inside the tamper-evident bags and plainly visible.
    [cir] Complete the second page of the Healthcare Provider 
Quality Checklist, including signature and date.
    [cir] Seal the bags.
    [cir] Attach the Healthcare Provider Quality Checklist to the 
Health Assessment Forms for the household.
    [cir] The doxycycline hyclate tablet emergency kits may then be 
dispensed to the USPS participant along with review of the 
instructions and information.
    The authorized Healthcare Provider Quality Checklist and placard 
information will be used. Any revision of the authorized Healthcare 
Provider Quality Checklist or placard information is subject to 
FDA's prior approval.
    F. ASPR will record the amount of unit-of-use bottles of 
doxycycline hyclate tablets (including lot numbers) shipped under 
this EUA to the participating public health authority(ies) for use 
by eligible USPS participants and their households. Such records 
will be made available to FDA for inspection upon request. However, 
the the participating public health authority(ies) responsible for 
distributing the doxycycline hyclate tablet emergency kits will 
prepare, maintain, and make available records and provide reports as 
directed by ASPR/FDA.
    G. Once an individual doxycycline hyclate tablet emergency kit 
has been dispensed to an eligible USPS participant, USPS will store 
the individual doxycycline hyclate tablet emergency kit in a secure 
location for the eligible USPS participant.
    H. ASPR, USPS, and the participating public health 
authority(ies) may only provide written materials as included in 
BARDA's October 3, 2008 submission, as amended on February 19, 2009, 
and authorized under this EUA. Any revisions or additional written 
materials to be provided by ASPR, USPS, or the participating public 
health authority(ies) are subject to FDA's prior approval, except 
that USPS may provide additional materials for recruitment purposes 
to the extent that those materials are consistent with the materials 
included in BARDA's October 3, 2008 submission, as amended on 
February 19, 2009, that are authorized under this EUA. The 
participating public health authority(ies) may evaluate activities 
undertaken pursuant to this authorization. To ensure consistency 
with this authorization, the participating public health 
authority(ies) must consult with FDA before conducting such 
evaluations.
    I. The participating public health authority(ies) will conduct 
an adverse event monitoring and reporting program designed to ensure 
that adverse events and medication errors associated with the use of 
the doxycycline hyclate tablet emergency kit are documented and 
reported within 15 days to MedWatch through www.fda.gov/medwatch, by 
submitting MedWatch Form 3500 in hard copy, or by calling 1-800-FDA-
1088; and that any such report identifies the product as 
``doxycycline hyclate tablet emergency kit'' and includes in the 
description of the event the designation ``USPS-CRI EUA'' or ``USPS-
CRI Emergency Use Authorization.'' As part of this program, health 
care providers will be provided copies of MedWatch Form 3500, 
recipients will be instructed to report if they take any of the 
doxycycline hyclate tablets in their emergency kit and experience an 
adverse event or medication error, MedWatch Form 3500 will be 
included in each doxycycline hyclate tablet emergency kit, and 
recipients will be provided with a toll-free number for contacting a 
health care provider if they experience an adverse event or 
medication error. The participating public health authority(ies) 
will maintain associated records until notified by FDA and will make 
such records available to FDA for inspection upon request.
    J. The participating public health authority(ies) will 
periodically verify and document that any undistributed doxycycline 
hyclate is within its labeled expiration date. The participating 
public health authority(ies) will maintain any associated records 
until notified by FDA and will make such records available to FDA 
for inspection upon request. Appropriate local public health 
authorities will periodically verify and reconcile drug 
accountability records.
    K. USPS will be responsible for providing USPS participants 
every six months with the Form entitled ``Questions to Determine 
Status of Your Household Antibiotic Kit (HAK)'' (Kit Status form) to 
document whether (a) they have stored their kits as instructed; (b) 
they are able to locate their kits readily; (c) their kits are 
intact; and (d) the doxycycline hyclate in their kits has not 
expired. USPS participants should complete these forms and mail them 
to the participating public health authority(ies) at the address 
provided. The participating public health authority(ies) will 
ascertain the circumstances surrounding non-compliance for USPS 
participants who (a) report loss of a kit; (b) report use of 
doxycycline hyclate from the emergency kit in the absence of 
instructions to do so; or (c) fail to return a completed Kit Status 
Form. Depending on its findings, the participating public health 
authority(ies) may disqualify an individual from further 
participation. If the doxycycline hyclate emergency kit will expire 
before the next 6-month follow-up, a new doxycycline hyclate 
emergency kit will be prescribed for eligible participants in 
accordance with paragraph D and the other terms of this letter. In 
such cases, USPS will be responsible for collecting such kits and 
turning them over to the participating public health authority(ies), 
which then will be responsible for accounting for them and disposing 
ofthem as instructed by ASPR. The participating public health 
authority(ies) will maintain drug accountability records. The 
participating public health authority(ies) will also

[[Page 30584]]

ascertain whether there have been any adverse events or medication 
errors associated with the doxycycline hyclate tablet emergency kit. 
If any such adverse events or medication errors have not previously 
been reported to FDA as outlined in paragraph H, they must be 
reported within 15 days to FDA. FDA has authorized ASPR's Form 
entitled ``Questions to Determine Status of Your Household 
Antibiotic Kit (HAK)'' (Kit Status form). Any revision of the Kit 
Status form is subject to FDA's prior approval. USPS, in conjunction 
with appropriate local public health authorities, will be 
responsible for ensuring that completed Kit Status forms are 
maintained until notified by FDA. A report summarizing the 
information collected on Kit Status forms under this paragraph will 
be submitted to FDA within 30 days of gathering such information. 
Associated records will be made available to FDA for inspection upon 
request.
    L. USPS will be responsible for collecting any expired 
doxycycline hyclate tablet emergency kits and turning them over to 
the participating public health authority(ies). The participating 
public health authority(ies) will be responsible for disposing of 
expired doxycycline hyclate tablet emergency kits as instructed by 
ASPR at that time. The participating public health authority(ies) 
will ensure that drug accountability records are maintained and 
reconciled. Such records shall be made available to FDA for 
inspection upon request.
    M. USPS and the participating public health authority(ies) will 
be responsible for ensuring that completed Health Assessment Forms, 
Healthcare Provider Quality Checklists, and any other records 
associated with this EUA are maintained until notified by FDA. Such 
records will be made available to FDA for inspection upon request.
    N. As a condition of this EUA, all advertising and promotional 
descriptive printed matter relating to the use of doxycycline 
hyclate tablet emergency kits authorized under this EUA shall be 
consistent with the Fact Sheets, home preparation instructions, and 
placard information, as well as the terms set forth in this EUA and 
other requirements set forth in the Act and FDA regulations.
    O. Upon termination of the declaration of emergency under 
section 564(b)(2) of the Act or upon revocation of this EUA under 
section 564(g) of the Act, USPS will be responsible for collecting 
all doxycycline hyclate tablet emergency kits and turning them over 
to the participating public health authority(ies). The participating 
public health authority(ies) will dispose of doxycycline hyclate 
emergency kits as instructed by ASPR at that time. The participating 
public health authority(ies) will ensure that drug accountability 
records are maintained and reconciled. Such records will be made 
available to FDA for inspection upon request.
    P. HHS will notify FDA of its decision to add a CRI location and 
its decision to initiate distribution of doxycycline hyclate tablet 
emergency kits under this EUA to particular CRI locations.
    The emergency use of doxycycline hyclate tablet emergency kits 
as described in this letter of authorization must comply with the 
conditions above and all other terms of this authorization.

V. Duration of Authorization

    This EUA will be effective until the declaration of emergency is 
terminated under section 564(b)(2) of the Act or the EUA is revoked 
under section 564(g) of the Act.
Randall W. Lutter, Ph.D.
Deputy Commissioner for Policy

    Dated: June 17, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-15044 Filed 6-25-09; 8:45 am]
BILLING CODE 4160-01-S